Therapeutic Efficacy of Risankizumab for Small Intestinal Lesions in Crohn’s Disease: A Retrospective Study Using Double-Balloon Endoscopy

Background: Risankizumab (RZB), an IL-23p19 monoclonal antibody, has demonstrated clinical efficacy in Crohn’s disease (CD), yet evidence regarding its effectiveness for deep small intestinal lesions remains scarce. These lesions are often underdiagnosed due to limited accessibility and subtle clinical presentation. Patients and Methods: We retrospectively analyzed 32 patients with moderate-to-severe CD who underwent total small intestinal evaluation by double-balloon endoscopy (DBE) both before and 8–14 months after RZB initiation in clinical practice. Endoscopic disease activity was assessed using the modified Simple Endoscopic Score for Crohn’s Disease (mSES-CD). Clinical response (CDAI), biomarker changes (CRP, LRG), and endoscopic outcomes were evaluated. Results: Mean mSES-CD significantly decreased from 14.3 to 8.2 (P < 0.001), indicating substantial mucosal improvement, particularly in the jejunum and deep ileum. Endoscopic remission (mSES-CD < 2) was achieved in 13.3% of patients. Clinical remission (CDAI <150) occurred in 80% at week 12 and was sustained in 56% at one year. Significant biomarker improvements were observed. No progression of strictures was seen during follow-up. Conclusions: This study confirms the therapeutic efficacy of RZB for deep small intestinal involvement in CD based on comprehensive DBE assessment. The results support the clinical utility of RZB in patients with refractory small intestinal lesions, highlighting its potential to maintain one year disease control when ongoing mucosal inflammation is a concern. These findings underscore the importance of deep enteroscopic evaluation to optimize therapeutic strategies.